TAS1440 + ATRA for Leukemia

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Taiho Oncology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TAS1440, alone and with ATRA, in patients with AML who didn't respond to previous treatments or whose cancer returned. It aims to see how the drug works in the body and if it can help treat the leukemia. Bisantrene, a new drug, has shown positive effects in earlier studies with manageable side effects.

Eligibility Criteria

This trial is for adults with acute myeloid leukemia (AML) who have not responded to standard treatments or whose disease has returned. They should be in a condition stable enough to complete at least one treatment cycle, have an acceptable level of organ function, and women must not be pregnant or breastfeeding. People with certain heart conditions, active infections, other cancers needing treatment, or those unable to take oral medication cannot join.

Inclusion Criteria

- AST and ALT <5 × ULN (if considered due to leukemic organ involvement).

I have a diagnosed condition.

My kidney function is within the normal range.

See 10 more

Exclusion Criteria

My bilirubin levels are high, or I have severe liver disease.

I am not undergoing active treatment for a second cancer, except if it's breast or prostate cancer being managed with hormone therapy.

I have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.

See 17 more

Treatment Details

Interventions

ATRA (Retinoid Receptor Agonist)
TAS1440 (Histone Deacetylase Inhibitor)

Trial OverviewThe study is testing TAS1440 alone and combined with ATRA in people with relapsed/refractory AML. It aims to evaluate the safety and effectiveness of these treatments over approximately 30 months. Participants will receive TAS1440 as a single agent first then in combination with ATRA.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: TAS1440 + ATRAExperimental Treatment1 Intervention

TAS1440 administered QD on specific days during each 28-day cycle in combination with ATRA twice daily (BID) in Part 2.

Group II: TAS1440Experimental Treatment1 Intervention

TAS1440 as a single agent administered once daily (QD) on specific days during each 28-day cycle in Part 1.